Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures

NCT02819427 | Unknown

• 1 other identifier: PI2012_843_0025
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted in children with typical or atypical "absence" epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording. Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.

Conditions

Epilepsy

Keywords

Spectroscopy, Near-Infrared; Electroencephalography; children

Outcome Measures

Primary Outcomes (1)

• haemodynamic changes

  haemodynamic changes by optical imaging, during the 4 interictal, preictal, ictal and postictal phases of absence seizures as defined by EEG analysis

  Day 0

Study Arms (1)

epilepsy

children with absence epilepsy presenting either typical or atypical seizures

Device: Near Infra Red Spectroscopy (NIRS); Device: Electroencephalography (EEG)

Interventions

Near Infra Red Spectroscopy (NIRS) DEVICE

epilepsy

Electroencephalography (EEG) DEVICE

Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

epilepsy

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with absence epilepsy presenting either typical or atypical seizures

You may qualify if:

• Children aged 3 to 14 years
• Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG

You may not qualify if:

• All children with severe congenital malformation
• Any refusal of a parent or child
• Any child with a serious deterioration in the general condition and vital functions
• Any child with dermatitis of the face or scalp
• Children under 3 years old or over 14 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Fabrice WALLOIS, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: April 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (1)